Alfa Scientific Designs, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Alfa Scientific Designs, Inc.” (first 1999, latest 2018), across 21 product codes in 4 review panels. Median 510(k) review time under this name: 147 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 124 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 330 |
| 2017 | 0 | — |
| 2018 | 2 | 132 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alfa Scientific Designs, Inc. took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 6 | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| DJC | Thin Layer Chromatography, Methamphetamine | 3 | 3 |
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| KHE | Reagent, Occult Blood | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 | 2 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 2 | 2 |
| DPK | Liquid Chromatography, Morphine | 2 | 2 |
Plus 11 more product codes.
Review panels
- Clinical Toxicology (32)
- Clinical Chemistry (7)
- Hematology (3)
- Microbiology (1)
Most recent Alfa Scientific Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | DKZ | 2018-02-23 | 128 |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | KHE | 2018-02-15 | 136 |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | DKZ | 2016-06-24 | 330 |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | DKZ | 2013-10-07 | 124 |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) | DJG | 2010-07-06 | 179 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | KHE | 2007-06-21 | 104 |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | DJG | 2007-05-07 | 164 |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | DJG | 2006-07-25 | 147 |
| K042227 | INSTANT-VIEW TROPONIN I TEST | MMI | 2004-11-19 | 94 |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | LYR | 2003-06-10 | 162 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alfa Scientific Designs, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alfa Wassermann Diagnostic Technologies, Inc. (21 510(k)s)
- Alfa Wassermann, Inc. (9 510(k)s)
- Alfa Biotech (Uk) , Ltd. (3 510(k)s)
- Alfa Wassermann Diagnostics Technologies, LLC (3 510(k)s)
- Alfa Tech Medical Systems, Ltd. (2 510(k)s)
- Alfa Wassermann Diagnostic Technologies, LLC (2 510(k)s)
- Alfa Gate Mazen, Ltd. (1 510(k)s)
- Alfa Technologies, Inc. (1 510(k)s)
- Alfa Thermodiagnostics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alfa Scientific Designs, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Alfa Scientific Designs, Inc.” (first 1999, latest 2018), across 21 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alfa Scientific Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alfa Scientific Designs, Inc. is 147 days.
Which FDA product codes appear under Alfa Scientific Designs, Inc.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 6); JHI (Visual, Pregnancy Hcg, Prescription Use, 4); DJC (Thin Layer Chromatography, Methamphetamine, 3).
Next steps
- See all 43 Alfa Scientific Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Alfa Scientific Designs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.